A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of Fluad-H5N1 and Seasonal Influenza Vaccine in Adult Subjects. - V87P5

ovartis Vaccines and Diagnostics0 sites400 target enrollmentStarted: October 21, 2014Last updated: October 27, 2014

Conditions

Drugs

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor
Enrollment: 400

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•1. Subjects aged 18 to 40 years of age who were mentally competent and who signed an informed consent form after having received a detailed explanation of the study protocol;
•2. Subjects who were in good health as determined by:
•? Medical history,
•? Physical examination,
•? Clinical judgment of the Investigator;
•3. Subjects who were able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 405
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•1. Who received another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever was longer, prior to enrollment and were unwilling to refuse participation in another clinical study through the end of the study;
•2. Who received influenza vaccination for current season 2007;
•3. Who experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy within the past 7 days;
•4. Who experienced fever (defined as axillary temperature =38.0°C) within 3 days prior to Visit 1;
•5. Who were Pregnant or breastfeeding;
•6. Females who refused to use an acceptable method of birth control for the duration of the study.
•7. Who had any serious disease, such as:
•b. Autoimmune disease (including rheumatoid arthritis),
•c. Diabetes mellitus,
•d. Chronic pulmonary disease,
•e. Acute or progressive hepatic disease,
•f. Acute or progressive renal disease;
•8. Who had surgery planned during the study period;
•9. Who had bleeding diathesis;
•10. Who had hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
•11. Who had history of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
•12. Who had known or suspected impairment/alteration of immune function, for
•example, resulting from:
•a. Receipt of immunosuppressive therapy (any corticosteroid therapy or cancer
•chemotherapy),
•b. Receipt of immunostimulants,
•c. High risk for developing an immunocompromising disease;
•13. Who had received another vaccine within 3 weeks prior and following each study vaccination;
•14. Who had history of (or current) drug or alcohol abuse that in the investigator’s opinion would interfere with safety of the subject or the evaluation of study objectives;
•15. Who had any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Investigators

Sponsor

ovartis Vaccines and Diagnostics

Similar Trials

Active, not recruiting

Phase 1

A Clinical Study to Compare the Effectiveness and Safety of Azacitidine Versus Pevonedistate Plus Azacitidine in Adults with Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Low-Blast Acute Myelogenous LeukemiaHigher-risk myelodysplastic syndromes (MDS), Chronic myelomonocytic leukemia (CMML), Low-blast acute myelogenous leukemia (AML)MedDRA version: 20.0Level: LLTClassification code 10054350Term: Chronic myelomonocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10024348Term: Leukemia myelogenousSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: LLTClassification code 10024330Term: Leukemia acuteSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851MedDRA version: 20.0Level: PTClassification code 10067387Term: Myelodysplastic syndrome transformationSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10009018Term: Chronic myelomonocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2015-000221-37-DEMillennium Pharmaceuticals, Inc. (Takeda)117

Active, not recruiting

Not Applicable

EUCTR2015-000221-37-ESMillennium Pharmaceuticals, Inc. (Takeda)117

Completed

Phase 2

A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Low-Blast Acute Myelogenous Leukemia10024324Leukemiacancer

NL-OMON45865Millennium Pharmaceuticals, Inc. (Takeda)6

Active, not recruiting

Phase 1

A Clinical Study to Compare the Effectiveness and Safety of Azacitidine Versus Pevonedistate Plus Azacitidine in Adults with Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Low-Blast Acute Myelogenous LeukemiaHigher-risk myelodysplastic syndromes (MDS), Chronic myelomonocytic leukemia (CMML), Low-blast acute myelogenous leukemia (AML)MedDRA version: 19.0Level: LLTClassification code 10054350Term: Chronic myelomonocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10024348Term: Leukemia myelogenousSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10024330Term: Leukemia acuteSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851MedDRA version: 19.0Level: PTClassification code 10067387Term: Myelodysplastic syndrome transformationSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10009018Term: Chronic myelomonocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2015-000221-37-FRMillennium Pharmaceuticals, Inc. (Takeda)117

Active, not recruiting

Phase 1

EUCTR2015-000221-37-CZMillennium Pharmaceuticals, Inc. (Takeda)117